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Ravimiamet lists October 2026 safety label changes for seven active substances

🇪🇪 Ravimiamet · Tue 03 Nov 2026

Estonia's medicines agency has published its monthly overview of safety-related product information updates, covering antimalarials, cancer therapies, an antibiotic, hormonal IUDs, a topical scabicide and growth hormone.

The Estonian State Agency of Medicines (Ravimiamet) has published on its website an overview of safety changes made to medicines information during October 2026. The overview was posted on 3 November.

According to the agency, such changes refine, among other things, warnings, adverse reactions, restrictions on use and interactions. The source does not detail what was changed for each product.

The October changes affect the following active substances: atovaquone with proguanil; binimetinib with encorafenib; levofloxacin; levonorgestrel in the intrauterine systems Fleree, Kyleena and Mirena; permethrin in gel form; and somatropin.

The updated product information can be found in the agency's section on safety changes in medicines information. Ravimiamet notes that the table covers only medicines marketed in Estonia.

What it means for your team

  • Marketing authorisation holders with products containing any of the seven listed substances or the named levonorgestrel IUDs should check the Ravimiamet section for the specific wording changes.
  • Pharmacovigilance teams should confirm whether the updates require action on Estonian product information, and align local labelling and any communication materials.
  • Because the table covers only products marketed in Estonia, companies without an Estonian presence will not find their products listed.
  • The published item gives no details of the changes themselves, so the underlying texts must be reviewed directly.

Official source: Ravimiamet ↗

Article written by VigiEye from the official source (Ravimiamet). AI-assisted; check the source before acting.

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